The U.S. Food and Drug Administration is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). 

According to the FDA, the test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. 

The FDA is concerned about the risk of false results when using this test because it says SML Distribution LLC has not provided the FDA with adequate data to show the test works correctly.

The FDA says it has not received reports of injuries or death associated with use of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).